(276 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a microcatheter, with no mention of AI or ML capabilities.
No
The device is described as assisting in the delivery of interventional devices and the infusion of diagnostic agents. It does not exert a therapeutic effect itself.
No
The device is a microcatheter intended for the infusion of diagnostic agents (like contrast media) and to assist in the delivery of interventional devices. It is a tool used during diagnostic procedures but does not itself perform the diagnosis.
No
The device description clearly details a physical catheter with various material components, a lumen, radiopaque markers, and a hydrophilic coating. The performance studies also focus on physical and biological properties of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "general intravascular use" for the "infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices". This describes a device used within the body for diagnostic imaging (with contrast) and therapeutic procedures (delivering other devices).
- Device Description: The description details a catheter designed for navigating blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside of the body) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve analyzing samples like blood, urine, or tissue.
This device is a medical device used in vivo (within the body) for diagnostic and interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Wedge Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices, such as the SOFIA 6F Catheter, in the neurovasculature.
Product codes
DQY
Device Description
The Wedge Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The microcatheter has a semi-rigid proximal section with an outer shaft made of Grilamid nylon. The catheter shaft transitions to progressively softer durometers and different lengths of Polyether block amide (Pebax). The distal-most length of the microcatheter, beyond the enlarged segment, consists of a softer, atraumatic polyurethane.
The enlarged segment on the distal end of the Wedge is designed to reduce the gap between the OD of the guidewire and ID of the Sofia 6F. The tapered bulb section, approximately 1 cm length and located approximately 1.5 cm from the distal tip, can be identified on fluoroscopy between the two radiopaque proximal marker bands of the Wedge Microcatheter. The bulb OD (0.068") is sized specifically to work with the lumen ID (0.070") of the Sofia 6F allowing for continuous flush of saline through the Sofia.
Three radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the microcatheter is coated with a hydrophilic polymer coating to reduce friction during navigation in the vasculature. The lubricious inner liner is made from polytetrafluoroethylene (PTFE). A luer fitting on the Microcatheter hub is used for the attachment of accessories. The hub/strain relief provides for the kink resistance at the proximal end. The microcatheter has a straight tip that is designed to be steam shaped by the physicians at the time of the use. A steam shaping mandrel and introducer sheath (accessories) are packaged with the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The results of verification and validation testing conducted on the subject device demonstrate that it performs as intended. Animal testing showed comparable acute performance/efficacy and safety parameters between the Wedge Microcatheter and predicate Headway 21, with no negative vascular events observed. Histopathology results confirmed no neointimal growth or stenosis, largely identical endothelial loss, and no vessel wall thinning or aneurysmal dilatation for both devices. Biocompatibility studies demonstrated the device to be non-cytotoxic, non-sensitizing, intracutaneously non-irritating, systemically non-toxic, non-pyrogenic, non-hemolytic, having no effect on clotting, non-complement activating, and non-thrombogenic.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.
April 5, 2018
MicroVention, Inc. Marina Emond Manager, Regulatory Affairs 1311 Valencia Avenue Tustin, California 92780
Re: K172014
Trade/Device Name: Wedge Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 1, 2018 Received: March 5, 2018
Dear Marina Emond:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/4 description: The image shows the text "Carlos L. Pena -S" in a simple, sans-serif font. The text is arranged horizontally, with a clear distinction between the first name, last name, and the suffix. The background is plain and does not distract from the text.
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172014
Device Name Wedge Microcatheter
Indications for Use (Describe)
The Wedge Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices, such as the SOFIA 6F Catheter, in the neurovasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) Summary - K172014
| Trade Name: | Wedge Microcatheter |
|---|---|
| Generic Name: | Percutaneous Catheter |
| Classification: | II, 21 CFR 870.1250, DQY |
| Submitted By: | MicroVention, Inc. |
| 1311 Valencia Ave | |
| Tustin, California, USA | |
| Contact: | Marina Emond |
| Manager, Regulatory Affairs | |
| Marina.Emond@Microvention.com | |
| (714) 247-8296 | |
| Date: | April 1, 2018 |
| Predicate Device: | Headway 21 Microcatheter (K093160) |
| Headway 17 Microcatheter (K083343) | |
| AXS Offset Delivery Assist Catheter (K163259) |
Device Description:
The Wedge Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The microcatheter has a semi-rigid proximal section with an outer shaft made of Grilamid nylon. The catheter shaft transitions to progressively softer durometers and different lengths of Polyether block amide (Pebax). The distal-most length of the microcatheter, beyond the enlarged segment, consists of a softer, atraumatic polyurethane.
The enlarged segment on the distal end of the Wedge is designed to reduce the gap between the OD of the guidewire and ID of the Sofia 6F. The tapered bulb section, approximately 1 cm length and located approximately 1.5 cm from the distal tip, can be identified on fluoroscopy between the two radiopaque
4
proximal marker bands of the Wedge Microcatheter. The bulb OD (0.068") is sized specifically to work with the lumen ID (0.070") of the Sofia 6F allowing for continuous flush of saline through the Sofia.
Three radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the microcatheter is coated with a hydrophilic polymer coating to reduce friction during navigation in the vasculature. The lubricious inner liner is made from polytetrafluoroethylene (PTFE). A luer fitting on the Microcatheter hub is used for the attachment of accessories. The hub/strain relief provides for the kink resistance at the proximal end. The microcatheter has a straight tip that is designed to be steam shaped by the physicians at the time of the use. A steam shaping mandrel and introducer sheath (accessories) are packaged with the catheter.
Indications for Use:
The Wedge Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices, such as the SOFIA 6F Catheter, in the neurovasculature.
Technological Characteristics and Product Feature Comparison:
The subject device, Wedge Microcatheter is substantially equivalent to the predicate devices in terms of:
- Intended use
- Scientific technology
- · Fundamental design
- · Materials and processes for packaging and sterilization of devices
A tabular comparison of the technological characteristics between the predicate devices and subject device is provided below.
5
| Device
Characteristics | Headway 17 Microcatheter
(K083343) | Headway 21 Microcatheter
(K093160) | AXS Offset Delivery Assist
Catheter (K163259) | Wedge Microcatheter
(Proposed) |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification/
Product Code | Class II/ DQY
(Percutaneous catheters) | Class II/ DQY
(Percutaneous catheters) | Class II/ DQY
(Percutaneous catheters) | Class II/ DQY
(Percutaneous catheters) |
| Intended Use | The Headway Microcatheter
is intended for general
intravascular use, including
the peripheral, coronary and
neuro vasculature for the
infusion of diagnostic
agents, such as contrast
media, and therapeutic
agents, such as occlusion
coils. | Intended for general
intravascular use, including
the peripheral, coronary and
neuro vasculature for the
infusion of diagnostic agents,
such as contrast media, and
therapeutic agents, such as
occlusion coils. | The AXS Offset Delivery
Assist Catheter is intended to
assist in the delivery of
interventional devices, such
as distal access catheters, in
the neurovasculature. | The Wedge Microcatheter
is intended for general
intravascular use,
including the peripheral,
coronary and neuro
vasculature for the
infusion of diagnostic
agents, such as contrast
media, and to assist in the
delivery of interventional
devices, such as the
SOFIA 6F Catheter, in
the neurovasculature. |
| Catheter OD | .025" -.031" | .028" - .034" | .050" | .028" - .034"
Equivalent to predicates |
| Catheter ID | .017" | .021" | .021" | .021"
Equivalent to predicates |
| Tip | Shapeable
15 cm | Shapeable
15 cm | Straight
2 cm | Shapeable, same as
predicates Headway 17
and Headway 21 |
| Device | Headway 17 Microcatheter | Headway 21 Microcatheter | AXS Offset Delivery Assist | Wedge Microcatheter |
| Characteristics | (K083343) | (K093160) | Catheter (K163259) | (Proposed) |
| Distal
segment/bulb | N/A | N/A | The distal outer diameter
(OD) of the AXS Offset
Catheter gradually increases
from 0.036in at the RO
Marker to 0.050in, 2 cm
proximal to the RO marker.
The bulb section with a
0.050in OD is maintained for
28 cm, then gradually
decreases towards the
proximal section. The overall
distal profile of the AXS
Offset catheter acts as a
smooth transition and
reduces the gap between the
outer diameter of a steerable
guidewire and inner diameter
of a DAC while allowing for
continuous saline flush
through the DAC. | Using the same principle
as the predicate AXS
Offset, the slightly
enlarged segment (bulb)
of the Wedge reduces the
gap between the outside
diameter of the guidewire
and the inside lumen of
the Sofia allowing for
continuous flush of saline
through the Sofia. |
| Effective
Length | $150 cm \pm 2$ | $150 cm \pm 2$ | 150 cm | 158-160 cm
Equivalent to predicates |
| Coating | Hydrophilic Coating | Hydrophilic Coating | Hydrophilic Coating | Hydrophilic coating of
the same composition as
predicates Headway 17
and Headway 21 to
reduce friction during use. |
| Hydrophilic
Coating Length | 100-105 cm | 100-105 cm | 80 cm | 110-115 cm
Equivalent to predicates |
| Device
Characteristics | Headway 17 Microcatheter
(K083343) | Headway 21 Microcatheter
(K093160) | AXS Offset Delivery Assist
Catheter (K163259) | Wedge Microcatheter
(Proposed) |
| Packaging | Material
Dispenser hoop:
Polyethylene
Mounting card:
Polyethylene
Pouch: Tyvek
Carton Box:
Bleached Sulfate | Same as Headway 17 | Catheter is placed in a
dispenser coil, then inserted
into a pouch and placed
inside a carton box. | Same as
predicates Headway 17
and Headway 21;
equivalent to AXS Offset. |
| | Package
Config.
Microcatheter is
placed in a
dispenser hoop
and accessories on
a mounting card
that is then
inserted into the
pouch. The pouch
is then placed
inside a carton
box. | | | |
| Method of
Supplying | Sterile and single use | Sterile and single use | Sterile and single use | Same |
| Method of
Sterilization | Ethylene oxide | Ethylene oxide | Ethylene oxide | Same |
Product Feature Comparison of Subject Device with Predicate Devices (K083343, K093160, K163259)
6
7
8
Verification Test Summary:
The results of verification and validation testing conducted on the subject device demonstrate that it performs as intended and are summarized as follows:
| Test Description | Result |
|---|---|
| Surface Contamination | Pass |
| Physical Attributes | Pass |
| Force at Break (Catheter Distal Section) | Pass |
| Force at Break (Catheter Hub Junction) | Pass |
| Freedom from Leakage (Low Pressure, Long Duration) | Pass |
| Freedom from Leakage (High Pressure, Short duration) | Pass |
| Freedom from Leakage - Air | Pass |
| Static Burst Pressure | Pass |
| Dynamic Burst Pressure | Pass |
| Coating Durability/Lubricity | Pass |
| Tip Shape and Tip Retention | Pass |
| Simulated Use | Pass |
| Flow Rate | Pass |
| Kink Resistance | Reference Only |
| Catheter Stiffness | Pass |
| Catheter Flexural Fatigue | Pass |
| Catheter Particle Testing | Pass |
| Dead Space | Reference Only |
| Torque Strength | Pass |
| Corrosion Resistance* | Pass |
| Gauging Test* | Pass |
| Separation Force* | Pass |
| Unscrewing Torque* | Pass |
| Resistance to Overriding* | Pass |
| Test Description | Result |
| Stress Cracking* | Pass |
| Radiopacity* (Visibility under fluoroscopy) | Pass |
| Pyrogenicity* | Pass |
| Ship Testing* | Pass |
| Shelf Life Testing | Pass |
9
" Testing was previously conducted on test article that was equivalent in all aspects relevant to the testing performed, therefore it was deemed unnecessary to repeat the testing for the Wedge Microcatheter.
Animal Testing Summary:
The acute performance/efficacy and safety parameters analyzed (insertion of introducer sheath into RHV, peel away introducer sheath from catheter, track test with guidewire, track test with guidewire/SOFIA 6F and overall performance) were comparable between the Wedge Microcatheter and predicate Headway 21 with no dissection, perforation, luminal narrowing, thrombus formation or distal emboli were noted for both test articles.
Histopathology Results: Morphometric measurements showed no neointimal growth or stenosis in both, the Wedge Microcatheter and predicate Headway 21, with largely identical endothelial loss and no incidence of vessel wall thinning or aneurysmal dilatation. There were no disruptions of the internal elastic lamina or medial layers in any vessel regardless of treatment device. Injury was limited to occasionally marked endothelial cell denudation without remarkable thrombus deposition in any treated vessel segment. Overall, the results of the study demonstrated substantial equivalence of the Wedge Microcatheter to the predicate.
Biocompatibility Evaluation:
The in vitro and in vivo biocompatibility safety studies performed on the Wedge Microcatheter have demonstrated the biocompatibility of the Wedge Microcatheter and support compliance with the ISO 10993-1:2009 and FDA guidelines. The device was determined to be non-cytotoxic, non-sensitizing, intracutaneously non-irritating, systemically non-toxic, non-pyrogenic (material-mediated), non-hemolytic, have no effect on clotting, non-complement activating, and non-thrombogenic. The results of biocompatibility evaluation are summarized as follows:
10
| Test | Test Summary | Conclusions |
|---|---|---|
| Cytotoxicity - Medium | ||
| Eluate Method | The test article extract exhibited between no cell lysis | |
| (grade 0) to slight reactivity (grade 1). | Non-cytotoxic | |
| Sensitization: | ||
| Maximization Test in | ||
| Guinea Pigs | No irritation was present on any of the test or negative | |
| control (0% sensitized) guinea pigs. | Non-sensitizer | |
| Intracutaneous Reactivity | No evidence of irritation (score 0.0). | Non-irritating |
| Systemic Injection Test in | ||
| Mice | No weight loss, mortality, or evidence of systemic | |
| toxicity from the extract exposure to the mice was | ||
| observed. | Systemically | |
| non-toxic | ||
| Rabbit Pyrogen Test | The rise of rabbit temperatures during the tree hours of | |
| observation did not exceed 0.5°C. | Nonpyrogenic | |
| ASTM Blood | ||
| Compatibility - Direct and | ||
| Indirect Contact Hemolysis | The test article demonstrated 0.59% hemolysis in direct | |
| contact and 1.25% hemolysis in indirect contact. | Non-hemolytic | |
| Unactivated Partial | ||
| Thromboplastion Time | ||
| Test | An average clotting time of the test article showed no | |
| significant difference from the control. | No effect on | |
| clotting | ||
| Complement Activation | The plasma exposed to the test article for 90 minutes was | |
| found to exhibit no statistically significant increase in | ||
| C3a. | Non-activated | |
| Thrombogenicity | Both animals exhibited no signs of toxicity during the | |
| study (score 0) | Non- | |
| thrombogenic |
Summary of Substantial Equivalence:
The information presented in this 510(k) demonstrates the substantial equivalence between the predicates Headway 21 Microcatheter (K093160), Headway 17 (K083343), AXS Offset (K163259), and the Wedge Microcatheter in regard to the design, construction materials, operating principle, and intended use.